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Common deficiencies with bioequivalence submissions in abbreviated new drug applications assessed by FDA. [electronic resource] by
- Liu, Qing
- Davit, Barbara M
- Cherstniakova, Svetlana A
- Dandamudi, Suman
- Walters, Johnetta F
- Lee, Christina H
- Raines, Kimberly W
- Ren, Ke
- Williamson, Leeh N
- Conner, Dale P
Producer: 20120618
In:
The AAPS journal vol. 14
Availability: No items available.
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Highly variable drugs: observations from bioequivalence data submitted to the FDA for new generic drug applications. [electronic resource] by
- Davit, Barbara M
- Conner, Dale P
- Fabian-Fritsch, Beth
- Haidar, Sam H
- Jiang, Xiaojian
- Patel, Devvrat T
- Seo, Paul R H
- Suh, Keri
- Thompson, Christina L
- Yu, Lawrence X
Producer: 20080922
In:
The AAPS journal vol. 10
Availability: No items available.
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Use of partial area under the curve metrics to assess bioequivalence of methylphenidate multiphasic modified release formulations. [electronic resource] by
- Stier, Ethan M
- Davit, Barbara M
- Chandaroy, Parthapratim
- Chen, Mei-Ling
- Fourie-Zirkelbach, Jeanne
- Jackson, Andre
- Kim, Stephanie
- Lionberger, Robert
- Mehta, Mehul
- Uppoor, Ramana S
- Wang, Yaning
- Yu, Lawrence
- Conner, Dale P
Producer: 20130404
In:
The AAPS journal vol. 14
Availability: No items available.
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Common reasons for "for-cause" inspections in bioequivalence studies submitted to the Food and Drug Administration. [electronic resource] by
- Li, Bing V
- Davit, Barbara M
- Lee, Christina H
- Pabba, Santhosh K
- Mahadevan, Chitra
- Caramenico, Hoainhon T
- Haidar, Sam H
- Sanchez, Aida L
- Sigler, Aaron W
- Stier, Ethan M
- Conner, Dale P
Producer: 20130802
In:
The AAPS journal vol. 15
Availability: No items available.
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20.
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Implementation of a reference-scaled average bioequivalence approach for highly variable generic drug products by the US Food and Drug Administration. [electronic resource] by
- Davit, Barbara M
- Chen, Mei-Ling
- Conner, Dale P
- Haidar, Sam H
- Kim, Stephanie
- Lee, Christina H
- Lionberger, Robert A
- Makhlouf, Fairouz T
- Nwakama, Patrick E
- Patel, Devvrat T
- Schuirmann, Donald J
- Yu, Lawrence X
Producer: 20130404
In:
The AAPS journal vol. 14
Availability: No items available.
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